The purpose of this study is to evaluate the safety and preliminary efficacy of CC-95266 in participants with relapsed and/or refractory multiple myeloma (R/R MM).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Local Institution - 005
Birmingham, Alabama, United States
Local Institution - 009
Duarte, California, United States
Local Institution - 012
San Francisco, California, United States
Number of participants with Adverse Events (AEs)
Time frame: Up to 2 years after CC-95266 infusion
Number of participants with significant laboratory abnormalities
Time frame: Up to 2 years after CC-95266 infusion
Number of participants with Dose Limiting Toxicities (DLTs)
Time frame: Up to 2 years after CC-95266 infusion
Maximum Tolerated Dose (MTD)
Time frame: Up to 2 years after CC-95266 infusion
Recommended Phase 2 Dose (RP2D)
Time frame: Up to 2 years after CC-95266 infusion
Pharmacokinetics - Maximum plasma concentration of drug (Cmax)
Time frame: Up to 2 years after CC-95266 infusion
Pharmacokinetics - Time to peak (maximum) serum concentration (tmax)
Time frame: Up to 2 years after CC-95266 infusion
Pharmacokinetics - Area under the curve for days 1-29 after CC-95266 infusion (AUC1-29)
Time frame: Up to 2 years after CC-95266 infusion
Overall response rate (ORR)
Time frame: Up to 2 years after CC-95266 infusion
Complete response rate (CRR)
Time frame: Up to 2 years after CC-95266 infusion
Very good partial response (VGPR) or better
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Specified dose on specified days
Local Institution - 002
Denver, Colorado, United States
Local Institution - 008
Baltimore, Maryland, United States
Local Institution - 010
Boston, Massachusetts, United States
Local Institution - 011
New York, New York, United States
Local Institution - 001
Nashville, Tennessee, United States
Local Institution - 006
Dallas, Texas, United States
Local Institution - 003
Seattle, Washington, United States
Time frame: Up to 2 years after CC-95266 infusion
Duration of response (DOR)
Time frame: Up to 2 years after CC-95266 infusion
Duration of complete response (DOCR)
Time frame: Up to 2 years after CC-95266 infusion
Time to response (TTR)
Time frame: Up to 2 years after CC-95266 infusion
Time to complete response (TTCR)
Time frame: Up to 2 years after CC-95266 infusion
Progression-free survival (PFS)
Time frame: Up to 2 years after CC-95266 infusion
Overall survival (OS)
Time frame: Up to 2 years after CC-95266 infusion